Newborn Screening Market: Analysis By Product, By Technology, By Test Type, By End User, By Region Size and Trends and Forecast up to 2029

Newborn screening is a public health program designed to identify genetic, metabolic, and congenital disorders in newborns shortly after birth. Through a series of tests, such as blood spot tests, hearing tests, and pulse oximetry, healthcare providers can detect conditions that may not be immediately apparent but could lead to serious health issues if untreated. Early detection allows for timely interventions, improving the chances of preventing disabilities or life-threatening complications. The global newborn screening market value in 2023 stood at US$1.24 billion, and is likely to reach US$2.16 billion by 2029.

The newborn screening market has experienced significant growth over the years primarily due to advancements in screening technologies. Innovations like tandem mass spectrometry, DNA assays, and pulse oximetry have significantly improved the accuracy, speed, and range of conditions that can be detected in newborns. These advancements allow for earlier and more reliable diagnoses, which can lead to timely interventions and better health outcomes, ultimately driving the demand for advanced screening tools and equipment in hospitals and government mandates for mandatory screening programs, and growing awareness about the importance of early diagnosis and treatment, have further propelled market growth. Other significant trends including AI and machine learning based newborn screening, point-of-care testing, advances in genomic and molecular technologies, expansion of screening panels, emerging markets, telehealth expansion etc. are expected to drive market growth further. The global newborn screening market value is projected to grow at a CAGR of 9.86%, during the forecast period of 2024-2029.

Market Segmentation Analysis:

By Product: According to the report, the global newborn screening market is bifurcated into two segments based on product type: Instruments and Reagents and assays. Instruments segment acquired majority of share in the market in 2023 and is expected to grow the fastest during forecasted period due to the growing adoption of advanced diagnostic equipment and technologies, which enable faster, more accurate, and comprehensive testing for multiple disorders in newborns. Additionally, continuous innovation in screening devices has increased their usage in hospitals and diagnostic labs.

The global newborn screening instruments market is further bifurcated into four segments: newborn disorder screening instruments, pulse oximeters, newborn hearing screening instruments, and other instruments. Newborn disorder screening instruments acquired majority of the share in 2023 and is expected to growth the fastest as well. The global newborn screening reagents and assays market is further bifurcated into two segments: Immunoassay and Enzymatic Assays and DNA-Based Assays. Immunoassay and Enzymatic Assays acquired majority of the share in 2023 and is expected to growth the fastest as well.

By Technology: According to the report, the global newborn screening market is bifurcated into six technologies: tandem mass spectrometry, pulse oximetry screening technology, immunoassays and enzymatic assays, DNA assays, electrophoresis and others. Tandem mass spectrometry segment acquired majority of share in the market in 2023 due to its ability to screen for multiple disorders simultaneously with high precision and speed. Its effectiveness in detecting metabolic and genetic conditions early in newborns has made it a preferred technology in hospitals and diagnostic labs globally. While, immunoassays and enzymatic assays are expected to be the fastest-growing segment due to their increasing use in detecting specific metabolic and genetic disorders with high sensitivity and specificity. The growing demand for targeted, disease-specific screening and the expanding range of conditions they can detect contribute to their rapid adoption in newborn screening programs.

By Test Type: According to the report, the global newborn screening market is bifurcated into four types of tests: dry blood spot test, critical congenital heart diseases (CCHD) test, hearing screen test, and others. Dry blood spot test segment acquired majority of share in the market in 2023 is expected to grow at the fastest CAGR during forecasted period, due to its ability to screen for a wide range of disorders from a single, minimally invasive sample. This test is cost-effective, easy to collect, transport, and store, making it ideal for large-scale screening programs, particularly in resource-limited settings. Additionally, its role in early detection of life-threatening conditions enhances its appeal, driving increased adoption across healthcare systems worldwide.

By End-user: The report further bifurcates the market into two end-users: hospitals and clinics and diagnostic labs. Hospitals and clinics segment acquired majority of share in the market in 2023 and is expected to grow fastest due to the centralized role they play in newborn care. Hospitals and clinics are the primary points for childbirth and immediate postnatal care, making them key locations for initial screenings. Additionally, the increasing number of births, coupled with government-mandated screening programs conducted in hospitals, has led to higher adoption of screening technologies and equipment in these settings, driving growth in this segment.

By Region: The report provides insight into the Newborn Screening market based on the geographical operations, namely, North America, Europe, Asia Pacific, and rest of the world. North America Newborn Screening market enjoyed the highest market share in 2023 due to well-established healthcare infrastructure, mandatory newborn screening programs across most states, and significant government support for early diagnosis of congenital disorders. Additionally, the presence of advanced screening technologies, high healthcare spending, and widespread awareness of the importance of early detection among healthcare professionals and parents further fueled the market’s dominance in the region.

While, Asia Pacific region has been experiencing the fastest growth in the global newborn screening market due to increasing birth rates, growing awareness about the importance of early diagnosis, and expanding government initiatives to implement mandatory screening programs in countries like China and India. Additionally, improvements in healthcare infrastructure, rising disposable incomes, and a growing demand for advanced diagnostic technologies in emerging economies have driven the rapid adoption of newborn screening across the region.

Global Newborn Screening Market Dynamics:

Growth Drivers: The rising burden of congenital diseases is a significant driver of growth in the global newborn screening market. As the prevalence of genetic and metabolic disorders increases, there is a heightened demand for early detection and intervention to improve patient outcomes and reduce long-term healthcare costs. Newborn screening programs enable early identification of these conditions, allowing for timely treatment and management that can prevent severe health issues and enhance quality of life. This growing need for early diagnosis is fueling the expansion of screening programs and the adoption of advanced technologies worldwide. Other factors driving the growth of global newborn screening market include rising birth rates and population growth, upsurge in healthcare expenditure, government initiatives and mandatory screening programs, increased awareness and education etc.

Challenges: Lack of standardization poses a significant challenge to the global newborn screening market by creating inconsistencies in screening practices and outcomes across different regions and healthcare systems. Variations in the types of tests used, protocols followed, and quality control measures can lead to disparities in the accuracy and reliability of screening results. This lack of uniformity not only affects the effectiveness of early disease detection but also complicates data comparison and analysis on a global scale, hindering the development of universally effective screening programs and potentially impacting patient outcomes. Other challenge might include regulatory hurdles.

Trends: Point-of-care testing is emerging as a key future trend in the global newborn screening market due to its potential to enhance the speed and convenience of testing. This approach involves conducting diagnostic tests at or near the location of patient care, such as in hospitals or clinics, rather than sending samples to centralized laboratories. By providing immediate results, point-of-care testing can facilitate quicker decision-making and earlier intervention, which is crucial for effective newborn screening. This trend is driven by advancements in technology that enable more compact, user-friendly devices and a growing emphasis on improving healthcare accessibility and efficiency. The market is also projected to grow at a fast pace during the forecast period, due to various other latest trends such as AI and machine learning based newborn screening, advances in genomic and molecular technologies, expansion of screening panels, emerging markets, telehealth expansion etc.

Competitive Landscape and Recent Developments:

The global newborn screening market is fragmented catering to domestic and international demand. Players operating in the global newborn screening market focus on providing high-quality products to fulfill customer demand. They also focus on strategies such as investments in research and development activities, new product launches, and expanding production capacities. Key players of global newborn screening market are:

• Agilent Technologies Inc
• Revvity Inc.
• Waters Corporation
• Bio-Rad Laboratories Inc.
• Masimo Corporation
• Medtronic plc
• LifeCell International Pvt. Ltd.
• Zentech
• Trivitron Healthcare
• MRC Holland
• Natus Medical Incorporated
• Baebies Inc.